Sucralfate

What is Sucralfate?

• Sucralfate (Carafate) is an α-D-glucopyranoside, β-D- fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex.
• It belongs to class of medications called protectants.

Sucralfate

What are the uses of this medicine?

Sucralfate (Carafate) is used in:

• Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.
• Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.

How does this medicine work?

Although the mechanism of sucralfate’s ability to accelerate healing of duodenal ulcers remains to be fully defined, it is known that it exerts its effect through a local, rather than systemic, action as fallows:

• sucralfate forms an ulcer-adherent complex with proteinaceous exudate at the ulcer site.
• sucralfate-albumin film provides a barrier to diffusion of hydrogen ions.
• sucralfate given in doses recommended for ulcer therapy inhibits pepsin activity in gastric juice by 32%.
• sucralfate adsorbs bile salts.

• sucralfate’s antiulcer activity is the result of formation of an ulcer-adherent complex that covers the ulcer site and protects it against further attack by acid, pepsin, and bile salts.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• with known hypersensitivity reactions to the active substance or to any of the excipients.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• anticoagulants ('blood thinners') such as warfarin (Coumadin)
• cimetidine (Tagamet)
• cinoxacin (Cinobac)
• ciprofloxacin (Cipro)
• digoxin (Lanoxin)
• enoxacin (Penetrex)
• ketoconazole (Nizoral)
• levofloxacin (Levaquin)
• levothyroxine (Levothroid, Levoxyl, Synthroid)
• lomefloxacin (Maxaquin)
• nalidixic acid (NegGram)
• norfloxacin (Noroxin)
• ofloxacin (Floxin)
• phenytoin (Dilantin, Phenytek)
• quinidine
• ranitidine (Zantac)
• sparfloxacin (Zagam)
• tetracycline
• theophylline (Theo-24)

• If you are taking any of these medicines, take them at least 2 hours before taking sucralfate.
• If you are taking antacids, take them at least 30 minutes before or after sucralfate.

Is this medicine FDA approved?

• Sucralfate was approved for medical use in the United States in 1981.
• It is available as a generic medication.
• In 2020, it was the 182nd most commonly prescribed medication in the United States, with more than 2 million prescriptions.

How should this medicine be used?

Recommended dosage: Active Duodenal Ulcer:

• The recommended adult oral dosage for duodenal ulcer is 1 g four times per day on an empty stomach.
• Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after sucralfate.
• While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.

Maintenance Therapy:

• The recommended adult oral dosage is 1 g twice a day.

Carafate Oral Suspension:

• The recommended adult oral dosage for duodenal ulcer is 1 gram (10 mL) four times per day.
• Carafate Oral Suspension should be administered on an empty stomach.
• Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after Carafate Oral Suspension.

Administration:

• Sucralfate comes as a tablet and liquid to take by mouth.
• If you are taking sucralfate to treat ulcers, the tablets or liquid usually are taken four times a day.
• If you are taking sucralfate to prevent an ulcer from returning after it has healed), the tablets usually are taken twice a day.
• Take sucralfate on an empty stomach, 2 hours after or 1 hour before meals.
• Take sucralfate around the same times every day.
• Shake the liquid well before each use to mix the medication evenly.
• This medicine must be taken regularly to be effective.
• It may take up to 8 weeks for ulcers to heal.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Carafate (sucralfate) 1 g tablets
• Carafate (sucralfate) Oral Suspension 1 g/10 mL

This medicine is available in fallowing brand namesː

• Carafate

What side effects can this medication cause?

The most common side effects of this medicine include:

• Constipation
• diarrhea
• nausea
• vomiting
• gastric discomfort
• indigestion
• flatulence
• dry mouth
• pruritus
• rash
• dizziness
• insomnia
• sleepiness
• vertigo
• back pain
• headache

Carafate may cause serious side effects which may include:

• hypersensitivity
• anaphylactic reactions
• bronchospasm
• laryngeal edema
• edema of the mouth
• Pharyngeal edema
• respiratory tract edema and swelling of the face
• Bezoars
• pulmonary and cerebral emboli

What special precautions should I follow?

• Sucralfate is not intended for intravenous administration.
• Duodenal ulcer is a chronic, recurrent disease. While short-term treatment with sucralfate can result in complete healing of the ulcer, a successful course of treatment with sucralfate should not be expected to alter the post healing frequency or severity of duodenal ulceration.
• sucralfate tablets should be used with caution by patients who have known conditions that may impair swallowing, such as recent or prolonged intubation, tracheostomy, prior history of aspiration, dysphagia, or any other conditions that may alter gag and cough reflexes, or diminish oropharyngeal coordination or motility.
• When sucralfate is administered orally, small amounts of aluminum are absorbed from the gastrointestinal tract. Concomitant use of sucralfate with other products that contain aluminum, such as aluminum-containing antacids, may increase the total body burden of aluminum. Sucralfate should be used with caution in patients with chronic renal failure.
• It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sucralfate is administered to a nursing woman.
• If you are taking antacids, take them at least 30 minutes before or after sucralfate.

What to do in case of emergency/overdose?

Symptoms of overdose may include: Sucralfate is only minimally absorbed from the gastrointestinal tract. Risks associated with acute overdosage should, therefore, be minimal. In rare reports describing sucralfate overdose, most patients remained asymptomatic. Those few reports where adverse events were described included symptoms of dyspepsia, abdominal pain, nausea, and vomiting.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Due to limited experience in humans with overdosage of sucralfate, no specific treatment recommendations can be given.

Can this medicine be used in pregnancy?

• There are, however, no adequate and well-controlled studies in pregnant women.
• Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• SUCRALFATE

Inactive ingredients:

• MAGNESIUM STEARATE
• CELLULOSE, MICROCRYSTALLINE
• D&C RED NO. 30
• FD&C BLUE NO. 1
• STARCH, CORN

Who manufactures and distributes this medicine?

Distributed by:

• Allergan USA, Inc.
• Madison, NJ

• Carafate® is a registered trademark of Aptalis Pharma Canada ULC, an Allergan affiliate.

What should I know about storage and disposal of this medication?

• Store at controlled room temperature 20-25°C (68-77°F).

• Dailymed label info on Sucralfate
• FDA Sucralfate

Sucralfate Resources
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